This position is responsible for supporting Chemistry Manufacturing and Controls (CMC) quality assurance operations and reports to the Director of Quality Assurance. It is a full-time position requiring in-depth experience in quality assurance operations as it relates to internal operations and collaborative processes with external vendors. This position is Quality Systems and pharmaceutical vendor/supplier focused; it entails management of both internal and external quality system processes related to vendor/supplier activities, and requires knowledge of applicable regulations (both US and international). This position has no reports, and may require domestic and international travel.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
The individual in this position will be accountable for the following:
- Maintenance of Vendor/Supplier Quality Documents as part of Intercept's Vendor Management program;
- Represent Quality in internal and external meetings and teleconferences;
- Maintain/use the electronic document management (EDMS) system and quality management system (QMS);
- Assist/generate/maintain Quality System metrics and reports for Intercept's executive team as well as part of the Vendor Management program;
- Gather data and generate Quality reports for internal/external use or regulatory submission (e.g., Annual Product Review, Annual Reports);
- Work with the Procurement Team, Supply Chain, internal stakeholders, and/or Vendors directly to facilitate Vendor/Supplier Qualification per Intercept Policy & Procedures;
- Assist & facilitate the scheduling of Vendor/Supplier audits and accordingly maintain the Vendor/Supplier module in the QMS;
- Assist in the management and processing of quality documents to ensure their compliance with internal SOPs and FDA regulations;
- Perform and/or assist in the performance of Quality Assurance Batch Record Review up to and including generation of a Certificate of Analysis, Certificate of Release, and maintaining a log of Product Disposition for generation of metrics and other reports as necessary;
- Ensure complete Batch Record History file is maintained per Intercept Policies and Procedures;
- Implementation/improvement of existing quality processes to ensure continuously appropriate/compliant operation of quality processes internally and with external vendors;
- Prepare/participate in on-site regulatory audits/inspections, and support vendor audits/inspections, as needed;
- Service as a resource for other departments within Intercept for facilitating the completion of and filing of Quality System documentation;
- Other duties as assigned.
Experience and Skills
- BS/BA in Organic Chemistry, Biochemistry, or a relevant science
- At least 5 years of pharmaceutical drug QA experience
- Fluent in English, both spoken and written
REQUIRED KNOWLEDGE AND ABILITIES:
- Working knowledge of the following:
- Internal quality system operations and collaborative oversight in a GXP regulated environment for pharmaceuticals, relating to product development and commercial manufacturing.
- QA oversight and collaboration with product development/vendors to facilitate the review, approval, and finalization of Vendor provided Quality Documentation related to the manufacture and testing of pharmaceutical Drug Substance and Drug Product under GMP.
- Quality principles and pharmaceutical industry trends.
- Applicable CFR, ICH, and GXP regulations
- Skills in the following areas:
- Strong verbal and written communication skills are essential
- Excellent organization and multi-tasking skills
- Exceptional interpersonal skills, positive attitude, and problem-solving capabilities
- Ability to work independently and prioritize with minimal daily instruction
- Ability to think strategically in order to improve current internal and vendor processes
- Proficient in the following areas and computer applications:
- Electronic Document Management Systems
- MS word
- Microsoft office
- Excel with emphasis in trend charting and data analysis.